ISO 14971 Medical Device Development & Risk Management

Become a Medical device development and risk management expert inline with ISO 14971:2019

What you'll learn
By completing this course you will gain a comprehensive knowledge of medical device development and risk management per ISO 14971:2019
Understand when and how to apply risk management through a the medical device lifecycle.
Understand how to plan a medical device development.
Gain a deep understanding of medical device design controls and systems engineering principles.
Understand how ISO 14971 relates to other important international standards including IEC 60601, IEC 62304 and ISO 13485.
Have a clear understand how to easily document design control and risk management activities.

Requirements
While prior experience in medical devices or risk management is beneficial, the course is structured to provide foundational knowledge and advanced insights. Both beginners and experienced professionals will benefit from the material.

Description
This comprehensive course provides an in-depth education on the application of risk management per ISO 14971:2019 during the design and development of medical devices.You will learn to avoid the major mistakes people make that stifle new medical device product developments. Access countless practical examples providing you with the knowledge to easily develop safe and effective medical devices in the fastest possible time. Peek behind the curtain at our medical device templates documentation pack designed to make your regulatory submissions a walk in the park.This course is designed for working professionals in the medical device industry, including (electronic, mechanical, system, firmware) engineers, software developers, firmware developers, data scientists, quality assurance specialists, regulatory affairs professionals, project managers, and others involved in medical device development and compliance.The course is fully aligned with ISO 14971:2019, the international standard for the application of risk management to medical devices. You will learn how to apply each phase of the risk management process outlined in the standard to medical device design and development.It is recommended to complete the course over 5 days, taking about 4 hours a day to complete, and upon successful completion, participants will be proficient in medical device development & the application of medical device risk management over the entire medical-device lifecycle.Start your journey today to become a medical device development & risk management expert.

Who this course is for:
This course is designed for working professionals in the medical device industry, including (electronic, mechanical, system, firmware) engineers, software developers, firmware developers, data scientists, quality assurance specialists, regulatory affairs professionals, project managers, and others involved in medical device development and compliance.